Biotech company Pharming Group NV, developing innovative products for the treatment of unmet medical needs, announces that it has reached mutual agreement with Esteve to return the rights to market Ruconest in Spain, Portugal, Andorra and Greece. SOBI will now take up the exclusive distribution rights in these countries, extending its territories for Ruconest to all European Union countries, Iceland, Norway and Switzerland.
Sijmen de Vries, CEO of Pharming, said “In addition to the new territories in the Balkans, North Africa and the Middle East announced earlier this month, SOBI now has exclusive rights for the commercialization of Ruconest (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE) in all European markets where the product has received market authorization through central European approval. We are confident that this agreement will optimize the commercial roll-out of Ruconest.”
Rhucin (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). Rhucin is produced through Pharming’s proprietary technology in milk of transgenic rabbits and in Europe is approved under the name Ruconest for treatment of acute angioedema attacks in patients with HAE. Rhucin has been granted orphan drug designation in the US for the treatment of acute attacks of HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the US Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals.